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0. Introduction 0. Introduction

1.1 General 1 Scope

1.2 Application 4.3 Determining the scope of the quality management system

2. Normative 2 Normative references

references

3. Terms and 3 Terms and definitions

definitions

4. Quality 4 Context of the organization

Management System

4.1 General 4.4 Quality management system and its processes

Requirements

4.2 Documentation 7.5 Documented information

Requirements

4.2.1 General 7.5.1 General

4.2.2 Quality Manual -

4.2.3 Control of 7.5 Documented Information

Documents

4.2.4 Control of 7.5 Documented Information

Records

5. Management 5 Leadership
Responsibility

5.1 Management 5.1 Leadership and commitment

Commitment

5.2 Customer Focus 5.1.2 Customer focus

5.3 Quality Policy 5.2 Policy

5.4 Planning 6 Planning

5.4.1 Quality 6.2 Quality objectives and planning to achieve them

Objectives

5.4.2 Quality 6.3 Planning of changes

Management System
Planning

5.5 Responsibility, 5.3 Organizational roles, responsibilities and authorities

Authority, and
Communication

5.5.1 Responsibility 5.3 Organizational roles, responsibilities and authorities

and Authority

5.5.2 Management -
Representative

5.5.3 Internal 7.4 Communication

Communications

5.6 Management 9.3 Management Review

Review

5.6.1 General 9.3.1 General

5.6.2 Review Input 9.3.2 Management Review Inputs

5.6.3 Review Output 9.3.3 Management Review Outputs

6. Resource 7.1 Resources

Management

6.1 Provision of 7.1 Resources

Resources

6.2 Human Resources 7.1.2 People

6.2.1 General 7.2 Competence

6.2.2 Competence, 7.2 Competence and 7.3 Awareness

Training, and
Awareness

6.3 Infrastructure 7.1.3 Infrastructure

6.4 Work Environment 7.1.4 Environment for the operation of processes

7. Product Realization 8 Operation

7.1 Planning of Product 8.1 Operational planning and control

Realization

7.2 Customer-Related 8.2 Requirements for products and services

Processes

7.2.1 Determination of 8.2.2 Determining of requirements related to products and services

Requirements Related
to the Product

7.2.2 Review of 8.2.3 Review of requirements related to products and services

Requirements Related
to the Product

7.2.3 Customer 8.2.1 Customer communication

Communication

7.3 Design and 8.3 Design and development of products and services
Development

7.3.1 Design and 8.3.2 Design and development planning

Development Planning

7.3.2 Design and 8.3.3 Design and development inputs

Development Inputs

7.3.3 Design and 8.3.5 Design and development outputs

Development Outputs

7.3.4 Design and 8.3.4 Design and development controls

Development Review

7.3.5 Design and 8.3.4 Design and development controls

Development
Verification

7.3.6 Design and 8.3.4 Design and development controls

Development
Validation
7.3.7 Control of Design 8.3.6 Design and development changes
and Development
Changes

7.4 Purchasing 8.4 Control of externally provided processes, products and services

7.4.1 Purchasing 8.4.1 General

Process

7.4.2 Purchasing 8.4.3 Information for external providers

Information

7.4.3 Verification of 8.4.2 Type and extent of control and 8.6 Release of products and services
Purchased Product

7.5 Production and 8.5 Production and service provision

Service Provision

7.5.1 Control of 8.5.1 Control of production and service provision

Production and Service
Provision

7.5.2 Validation of 8.5.1 Control of production and service provision

Processes for
Production and Service
Provision

7.5.3 Identification and 8.5.2 Identification and traceability

Traceability

7.5.4 Customer 8.5.3 Property belonging to customers or external providers

Property

7.5.5 Preservation of 8.5.4 Preservation

Product

7.6 Control of 8.5.1 Control of production and service provision

Monitoring and
Measuring Equipment

8. Measurement, 9.1 Monitoring, measurement, analysis and evaluation

Analysis, and
Improvement

8.1 General 9.1.1 General

8.2 Monitoring and 9.1.1 General

Measurement

8.2.1 Customer 9.1.2 Customer satisfaction

Satisfaction

8.2.2 Internal Audit 9.2 Internal Audit

8.2.3 Monitoring and 9.1.3 Analysis and evaluation

Measurement of
Processes

8.2.4 Monitoring and 8.6 Release of products and services

Measurement of
Product

8.3 Control of 8.7 Control of nonconforming outputs

Nonconforming
Product

8.4 Analysis of Data 9.1.3 Analysis and evaluation

8.5 Improvement 10 Improvement

8.5.1 Continual 10.3 Continual improvement

Improvement

8.5.2 Corrective Action 10.2 Nonconformity and corrective action

8.5.3 Preventive Action 6.1 Actions to address risks and opportunities